Palmitoylethanolamide for treating functional dyspepsia
THE EFFECT OF DIETARY SUPPLEMENTATION WITH PALMITOYLETHANOLAMIDE ON GASTROINTESTINAL SYMPTOMS IN FUNCTIONAL DYSPEPSIA PATIENTS.
This study tests if taking palmitoylethanolamide can help people with functional dyspepsia feel better over eight weeks compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT05877781 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effects of palmitoylethanolamide (PEA) supplementation on symptoms of functional dyspepsia in a randomized, double-blind, placebo-controlled format. Participants will receive either PEA or a placebo three times daily for eight weeks, with symptom improvement assessed using the Leeds Dyspepsia Score (LPDS) questionnaire. Additionally, the study will investigate the impact of PEA on duodenal mucosal permeability. The goal is to determine the efficacy of PEA in alleviating dyspepsia symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with functional dyspepsia according to the Rome IV criteria.
Not a fit: Patients with conditions other than functional dyspepsia or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from functional dyspepsia.
How similar studies have performed: While the specific use of PEA for functional dyspepsia is novel, similar studies on PEA have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with functional dyspepsia as diagnosed by the Rome IV criteria. * Subjects must provide witnessed written informed consent prior to any study procedures being performed. * Subjects aged 18-70 years old. * Male or female subjects. * Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements. * Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. Exclusion Criteria: * Presence of a history of gastrointestinal surgery other than appendectomy and cholecystectomy. * Organic gastro-intestinal disease * Major psychiatric disorder such as major depression * Presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease. * Patients with eosinophilic esophagitis * Presence of diabetes mellitus * Active H. Pylori infection or \< 6 months after eradication * Predominant IBS (based on the Rome IV questionnaire) * Predominant GERD (based on the Rome IV questionnaire) * Patients taking prohibited medication * Females who are pregnant or lactating * Patients not capable to understand or be compliant with the study.
Where this trial is running
Leuven, Vlaams-Brabant
- KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.